Skip to main content
Clinical Trials/NCT02197520
NCT02197520CompletedPhase 1

The Effect of Treatment With Basal Insulin Peglispro or Insulin Glargine on Insulin Sensitivity and the Effect of Prandial Insulin Lispro in Patients With Type 2 Diabetes Mellitus

Eli Lilly and Company1 site in 1 country24 target enrollmentStarted: July 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)

Study Overview

Brief Summary

This study will look into insulin sensitivity (how the body responds to insulin) and effects of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has two treatment periods, each of which will last about four weeks. One drug (insulin peglispro or insulin glargine) will be administered in each period. Participants will receive both drugs during the study. Participants may remain on stable dose metformin, as prescribed by their personal physician.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Stable glycated hemoglobin (HbA1c) less than (<) 10.0 percent (%)
  • Stable dose of either 0.2 to 1.5 units per kilogram per day (U/kg/day) basal insulin or a total daily insulin dose l<2.0 units per kilogram (U/kg)
  • C-peptide <0.3 nanomole per liter (nmol/L)
  • Stable body during the last 2 months

Exclusion Criteria

  • Corrected QT interval (QTc) prolongation greater than (>) 500 milliseconds (ms) or have any other abnormality in the 12 lead
  • Abnormal blood pressure
  • A history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus (T1DM)), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Currently treated with oral antidiabetic drugs (OADs) (excluding metformin and dipeptidyl peptidase-4 (DPP4) inhibitors), or glucagon-like peptide-1 (GLP-1) agonists or intend to use over-the counter or prescription medication, herbal medications, or nutritional supplements that affect PG or insulin sensitivity, impact on hypoglycemic awareness or promote weight loss within 4 weeks prior to randomization
  • Fasting triglycerides (TGs) >400 milligrams per deciliter (mg/dL) (4.52 millimoles per liter (mmol/L))
  • Have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) within 4 weeks prior to randomization
  • Currently receive insulin by pump or insulin degludec
  • Poorly controlled diabetes or known to have poor awareness of hypoglycemia
  • History of gastroparesis or gastrointestinal malabsorption
  • Require treatment with any drug other than insulin to treat diabetes
  • Previous history of proliferative retinopathy
  • Excessive consumers of xanthines

Arms & Interventions

Insulin Peglispro (with Insulin Lispro)

Experimental

Insulin peglispro, a once daily subcutaneous(SC) injection at bedtime for 5 weeks

Intervention: Insulin Peglispro (Drug)

Insulin Peglispro (with Insulin Lispro)

Experimental

Insulin peglispro, a once daily subcutaneous(SC) injection at bedtime for 5 weeks

Intervention: Insulin Lispro (Drug)

Insulin Glargine (with Insulin Lispro)

Active Comparator

Insulin glargine, a once daily subcutaneous(SC) injection at bedtime for 5 weeks

Intervention: Insulin Glargine (Drug)

Insulin Glargine (with Insulin Lispro)

Active Comparator

Insulin glargine, a once daily subcutaneous(SC) injection at bedtime for 5 weeks

Intervention: Insulin Lispro (Drug)

Outcomes

Primary Outcomes

Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)

Time Frame: Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clamp

During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure.

Secondary Outcomes

  • Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro(Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast)
  • Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro(Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast)
  • Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen(Day 29:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast)
  • Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29(Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast)
  • Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp(Day 33 during euglycemic 2-step hyperinsulinemic clamp)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials